FSMA Intentional Adulteration Final Rule – US FDA Mitigation Strategies Update

This week afforded us another excellent installment of the webinar series with US Food and Drug Administration (FDA) experts. A further discuss of the Intentional Adulteration (IA) Rule was very informative. The focus of this call was Mitigation Strategies.

I thought I would highlight some important take-aways that I made note of and that may assist my Food Defense colleagues out there who missed this call.

  1. The FDA outlined several Key Terms with very specific meanings in the IA world worth noting:
    1. Vulnerability – The susceptibility of a point, step or procedure in a facility’s food process to IA.
    2. Significant Vulnerability (SV) – A vulnerability that, if exploited, could reasonably be expected to cause wide scale public health harm. A SV is identified by a vulnerability assessment.
    3. Actionable Process Step – A point, step, or procedure in a food process where a significant vulnerability exists.
    4. Mitigation Strategies – Those risk-based, reasonably appropriate measures that a person knowledgeable about food defense would employ to significantly minimize or prevent significant vulnerabilities identified at actionable process steps, and that are consistent with the current scientific understanding of food defense at the time of the analysis.
  1. As we are all aware, the IA Rule requires a Food Defense Plan that includes:
    1. Vulnerability Assessment
    2. Mitigation Strategies
    3. Procedures for food defense monitoring
    4. Food defense corrective action procedures
    5. Food defense verification procedures
  • Training
  • Reanalysis
  • Records

On the August 22, 2017 call, the FDA representative eluded to the fact that FDA tools such as CARVER + Shock and the Food Defense Plan Builder were dated. Therefore the FDA was not going to be prescriptive as to what vulnerability assessment model companies should use. One of the more significant discussions on the October 24th call was the fact that the FDA now considers CARVER + Shock was consistent with the old voluntary food defense program, but not compliant with the new IA Final Rule.

If you have ever used CARVER + Shock as a private corporation you understand the tremendous resources, and costs associated with assembling those resources required to do CARVER + Shock correctly. It was designed by the government and more specifically the military. They can afford those $3,500 hammers and $5,000 bolts! The FDA said they are also working on the revision of their Food Defense Plan Builder to bring that tool in line with the IA Final Rule.

This is good news for the food industry, as there are more cost-effective ways to get this vulnerability assessment work done. With our combined experience of almost 100 years, Premier Risk Solutions (PRS) can tailor a program to the client’s requirements.

Speaking to that tailoring, the FDA spoke to the fact that existing practices and procedures MAY address the requirements for mitigation strategies for your significant vulnerabilities that are linked to your Actionable Process Steps. PRS has been promoting this fact for many, many months. This is important to note, as our food defense team can easily identify these Actionable Process Steps and then work with your manufacturing and quality experts to determine what existing processes and procedures can meet the documentation requirements for the IA Rule.

Here is one very simple example…

As part of your food safety regime, your mixing area may have strict access control policies that are under the constant surveillance of your video monitoring system. When production staff leave the mixing area to retrieve more ingredients, a cover and locking devices are placed on the mixing tanks to guard against contamination, unintentional adulteration, and now combating insider threats leading to Intentional Adulteration.

By documenting the Key Process Steps vulnerability assessments, you have commissioned, these existing protocols, along with recommended enhancements can be fully documented in your Food Defense Plan. PRS can serve as your vulnerability expert, reviewing characteristics that are inherent to a process, then examine existing measures that are already being applied to this process by your Occupational Safety, Food Safety, Quality Control, Corporate Security, and other teams.

PRS is highly skilled at the identification of vulnerabilities and reviewing all existing policies, procedures, and processes. We conduct a “Pre-Assessment”, where we collect large amounts of site data. We carefully comb through these materials before coming on your site, and upon completion of the vulnerability assessment, we engage with your various teams to flush these existing good practices out. This saves time and money, while giving credit to the internal teams that have already devised great food safety and defense policy and procedures.

As the FDA call outlined, the IA Final Rule requires a consistent and proper implementation of the mitigation strategies, and this includes a Mitigation Management Program.

This management program must accommodate:

  • Food Defense Monitoring
  • Food Defense Corrective Actions
  • Food Defense Verification

While the FDA allows facilities flexibility in the identification of these procedures and determining the appropriate frequency, a qualified person must undertake the vulnerability assessment and documentation work.

You can access a copy of the FDA Final Rule Fact Sheet here.

Joe Zaccaria
Joe Zaccaria

Joe Zaccaria, CFDC serves as Managing Director | Consulting for Premier Risk Solutions. Joe lived and worked in Asia for many years, serving in a similar role for a global security organization. He then lived and worked in Canada for 15 years. Joe began his career in law enforcement and has engaged in global crisis security response for over 25 years. He is a Certified Food Defense Coordinator and has performed many food defense vulnerability assessments for large food production operations. He has performed over 600 risk assessments and 500 CPTED reviews for clients in banking, stock exchanges, high-tech, healthcare, manufacturing and many more. Joe is passionate about listening to client needs and providing kick-ass consulting solutions. He lives in and volunteers in emergency management in Blaine, WA. Joe holds several radio licenses and is a licensed Amateur Radio Operator – W7BWA.

You can reach him via:

Email: Joe@PremierRiskSolutions.com
You can book a call with Joe through this calendar link: calendly.com/joez